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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number UNKNOWN
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
Based on additional information received on 06-apr-2018 from a physician, the case was medically confirmed. Also the case was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as required intervention. This unsolicited case from united states was received on 28-feb-2018 from the patient. This case concerns a (b)(6) male patient who received treatment with synvisc one injection and the same day the knee was worse/pain worsen after injection, swelling in right knee/r knee was 4 times the size of original knee/on one side of r knee there was big baseball size swelling/around knee it blew up 4 times its size/it was so bad he could not walk, pain in right knee/painful/it was sore that evening/pain worsen after injection/ knee became painful; after one day the patient dragged the knee around when he did try to walk/ swelling was so bad he could not walk/was dragging it, it was stiff, warm/right knee only was very warm and drained 90 cc of fluid from the right knee/ large effusion without erythema or warmth. Also the reported lot number had device malfunction and the patient had diffuse tenderness and limited range of motion after unknown latency. No relevant concurrent condition was reported. Medical history included osteoarthritis (oa) in the right knee, ca prostate, blurred vision, frequent colds, heartburn, arthritis, joint pain, stiffness and muscular pain and diabetes. Surgical history included cardiac, carpal tunnel left wrist, arthroscopy right elbow, arthroscopy right shoulder, arthroscopy right knee, carpal tunnel right wrist, arthroscopy left elbow, arthroscopy left knee and prostate r trigger thumb release ((b)(6) 2017). Patient's father had history of cancer. Mother had history of diabetes. Sibling had history of diabetes, osteoporosis and kidney disease. Patient was allergic to sulfa drugs. Patient received synvisc series of 3 injections but every 6 months (in (b)(6) 2015) without any issue and synvisc one in the right knee. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at the dose of 6 ml, once (lot number: 7rsl021 and expiration date: 31-may-2020) in the right knee for osteoarthritis. The same day, in the evening patient experienced swelling and pain in the right knee. Patient tried icing the knee with no significant reduction in swelling. Patient denied any numbness or tingling and injury. The next morning the right knee was 4 times the size of the original knee, it was stiff, painful, and warm (latency: 1 day). Patient could not walk around without pain and he dragged the knee around when he did try to walk. On (b)(6) 2017, on examination, right knee showed large effusion without erythema or warmth. There was diffuse tenderness and the patient tolerated limited range of motion secondary to pain and swelling on an unknown date in (b)(6) 2017 (latency: unknown). Patient was informed that his large knee effusion had resulted from a reaction to synvisc injection. Patient was advised if he was to have synvisc injections again, he should proceed with the synvisc 3 series instead of synvisc one. Patient was also informed about significant arthritis in knee and might need a knee replacement in future. Later, in the second morning the knee was worse and patient went to the doctor and the doctor drained 90 cc of fluid from the right knee. Patient tolerated the procedure well and was injected 1 cc of betamethasone. Patient said the swelling went down after the knee was drained. Patient said the right knee still had pain from the oa but was slightly less than it was prior to synvisc one injection. Corrective treatment: drained and betamethasone for drained 90 cc of fluid from the right knee/ large effusion without erythema or warmth; ice and betamethasone for pain in right knee/painful/it was sore that evening/pain worsen after injection/ knee became painful, swelling in right knee/r knee was 4 times the size of original knee/on one side of r knee there was big baseball size swelling/around knee it blew up 4 times its size/it was so bad he could not walk and not reported for other events. Outcome: not recovered for device malfunction, knee was worse/pain worsen after injection and recovering for pain in right knee/painful/it was sore that evening/pain worsen after injection/knee became painful; unknown. For diffuse tenderness and limited range of motion; recovered for rest an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: required intervention for device malfunction, drained 90 cc of fluid from the right knee/ large effusion without erythema or warmth, pain in right knee/painful/it was sore that evening/pain worsen after injection/ knee became painful, swelling in right knee/r knee was 4 times the size of original knee/on one side of r knee there was big baseball size swelling/around knee it blew up 4 times its size/it was so bad he could not walk additional information was received on 06-apr-2018 from physician. The case was medically confirmed. The case was upgraded to serious. Patient's age, weight and height were added. Medical history, concomitant medications were added. Additional events of device malfunction, diffuse tenderness and limited range of motion were added along with details. The event term pain in right knee/painful/it was sore that evening/pain worsen after injection was updated to pain in right knee/painful/it was sore that evening/pain worsen after injection/ knee became painful, drained 90 cc of fluid from the right knee was updated to drained 90 cc of fluid from the right knee/ large effusion without erythema or warmth. Corrective treatment for pain in right knee/painful/it was sore that evening/pain worsen after injection/ knee became painful, swelling in right knee/r knee was 4 times the size of original knee/on one side of r knee there was big baseball size swelling/around knee it blew up 4 times its size/it was so bad he could not walk were added. Corrective treatment (betamethasone) was added for drained 90 cc of fluid from the right knee/ large effusion without erythema or warmth. Outcome of pain in right knee/painful/it was sore that evening/pain worsen after injection/knee became painful was updated from not recovered to recovering. Treatment start and stop date, lot number and expiry date of synvisc one was added. Investigation summary was added. Clinical course was updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 6-apr-2018: the events have been assessed as related to the product as the events occured in close approximation to the occurence of product administration, hence a significant temporal relationship can be established. Furthermore, the concerned lot number has been identified to have malfunction by the company. However, information regarding medical history, concomitant medications, investigation details and past drugs can aid in complete medical assessment of the case.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7479961
MDR Text Key107745406
Report Number2246315-2018-00461
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Remedial Action Recall
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
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